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Letter to HHS Secretary Sebelius Regarding Specialty Compounding

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Public Citizen urges Secretary of Health and Human Services Kathleen Sebelius to direct the Food and Drug Administration (FDA) to seek an injunction against Specialty Compounding, a Texas compounding pharmacy cited by FDA inspectors for multiple sterility concerns in March 2013. We also urge that the Inspector General conduct an investigation to determine why the FDA did not request an earlier voluntary recall, issue a public safety alert, or seek an injunction after inspectors noted the serious quality control problems. Further actions should be initiated against all pharmacies with quality control problems similar to those of Specialty Compounding. Since fall of 2012, “significant objectionable conditions” have been identified at 50 compounding pharmacy facilities, yet only 16 of these facilities have initiated a product recall or been the subject of an FDA enforcement action.

August 19, 2013, Initial response from HHS

November 20, 2013, Response from FDA